How to Access the HSPP Policies and Procedures...
The HSPP Policies and Procedures provide guidance and information for investigators conducting all types of human subjects research. Please refer to these Policies and Procedures in the prepartion and conduct of all human subjects research.
HSPP Policies and Procedures

How To Submit a New Proposal...
All investigators must submit new IRB applications using the iStar System. For information on how to submit the new proposals, including new grants or contracts to the IRB, visit the iStar website at http://istar-chla.usc.edu.

On the left side of the iStar Home page, you will find a “General Information” section. If this is your first time to use iStar as an investigator, please click on “Information for Investigators”, to help understand iStar system and online submission process.

To request an iStar account by e-mail:

1. Put iStar Account Request in the subject line of an email.
3. Include in the body of the email, Your name, campus*, division and department, and email address.
4. Send the email to istar@usc.edu.

* Specify campus as either USC - Health Sciences, USC - University Park, or Childrens Hospital LA.

To talk to or leave a message for the iStar help desk by phone: Call (323)-223-2340

How To Submit a Continuing Review...
All continuing reviews (progress reports) will be processed via iStar. The Principal Investigators will receive Continuing Review notifications via e-mail. The first notification will be sent out 60 days before the study expiration date; the second notification, 45 days before; the third notification, 30 days before; and the final notice on the day of expiration. The third and the final notifications will be sent to both the PI and Co-investigators and any other personnel specified in iStar application.

Please note that if the expiration date has lapsed, the investigator must formally request (e-mail or telephone is acceptable) to continue with study subjects currently on the trial and/or continue data analysis. The investigator will receive written confirmation from the IRB. The investigator may not enter new subjects until the study’s continuing review has been reviewed and approved. The investigator will receive a separate letter at that time.
iStar website http://istar-chla.usc.edu

How to Submit an Amendment to a Previously Approved Protocol...
Revisions and Amendments to proposals/studies must be submitted via iStar. The proposed changes may not be implemented in the study until the IRB issues an approval letter. The only exception is a change necessary to eliminate apparent immediate hazards to the research subjects. In such a case, the IRB should be promptly informed of the change following its implementation for review.

Click the “New Amendment” tab in the study workspace to submit any revision or amendment to your proposal to the IRB. Answer the questions in the Amendment Smart Form. If you need some guidance as to how to answer Smart Form questions, click on “Guidance”, on the right hand side of the screen.
iStar website http://istar-chla.usc.edu

How to Submit a Reportable Event to a Previously Approved Protocol...
Any Reportable Events (internal or external adverse events, DSM reports, protocol deviations/errors) must be submitted via iStar, if the proposals/studies have been submitted via iStar or converted into electronic system from an original paper submission.

Click on “New Reportable Event” in the study workspace to submit the reportable events. Answer the questions in the Reportable Event Smart Form. The Smart Form will guide you through the necessary questions for you to complete the report. If you need some guidance as to how to answer Smart Form questions, click on “Guidance” on the right hand side of the screen.
iStar website http://istar-chla.usc.edu